MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number	105-5082-145
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a solitaire fr thrombectomy stent was introduced through a y-valve into the rebar-27 microcatheter, ready for delivery to the thrombus site.When the stent reached the distal end of the microcatheter, the stent met resistance and could not be advanced out despite repeated adjustments.It was also noted that the resistance was in the sheath.The product was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing an mechanical thrombectomy surgery for treatment of a ischemic stroke in the m1 segment of the middle cerebral artery.It was noted the patient's vessel tortuosity was moderate and the patient's medical history includes hypertension.The patient's baseline modified rankin score (mrs) was 3 and was 1 post-procedure.The national institutes of health stroke scale (nihss) score improved , decreasing from baseline score of 15 to 5 post-procedure.The thrombolysis in cerebral infarction (tici) score also improved from 3 at baseline to 5 post-procedure.Intravenous tissue plasminogen activator (iv tpa) was contraindicated in this case.The procedure involved two passes with the device.The stroke onset to reperfusion time was 10 hours.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
Continuation of d10: solitaire fr 6x30 model number: sfr-6-30 serial: (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received clarified that the resistance was at the distal end of the catheter.The catheter flush was administered per ifu during the procedure.There was no kink or damage on the catheter or solitaire pushwire.Of the solitaire.The tip of the solitaire sheath was secured into the hub of the microcatheter.The rhv was secured during delivery.The cause of the resistance was not determined.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Update: d3, d4, h3, and h4.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; carretera san isidro, km 17; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; carretera san isidro, km 17; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23109973
• Report Number: 9612501-2025-02486
• Device Sequence Number: 10082778
• Product Code: KRA
• UDI-Device Identifier: 00763000539368
• UDI-Public: (01)00763000539368(17)270325(10)D028093
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-5082-145
• Device Catalogue Number: 105-5082-145
• Device Lot Number: D028093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 10/24/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/23/2025; 11/22/2025
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 73 KG